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#702: Cross-Functional Agentic End-to-End Dossier Preparation: Where are we Today and Progress Towards Realizing the Vision
Thursday June 18, 2026 8:00am - 9:00am EDT
109AB
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-644-L04-P; CME 1.00; RN 1.00

As pharma companies set increasingly bold ambitions for productivity, technology is more crucial than ever. This session presents a vision for how productivity can be boosted end-to-end with Agentic AI, with humans working alongside agents.

Learning Objectives

Describe recent trends in regulatory submission preparation acceleration, including role of technology; Discuss a vision for how Agentic AI can underpin each step of submission dossier preparation.

Chair

Anton Mihic, MSC

Speaker

Agentic AI for statistical programming and rapid biostatistical analysis
Ralf Raschke

Panel discussion: Learnings from AI-enabled clinical and regulatory decision making
Jennings Xu

Panel discussion: Learnings from AI-enabled regulatory submissions
Cassie Gregson

Panel discussion: Learnings from AI-enabled end-to-end dossier generation
Andrea Doyle


Speakers
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Andrea Doyle

Global Regulatory Affairs NA Head, Sanofi, United States
Andrea Doyle is Global Regulatory Affairs Head of Region North America (NA) and Global Advertising and Promotion at Sanofi. She provides oversight and regulatory expertise to optimize development programs and leads Global Advertising and promotion to deliver dynamic solutions to support... Read More →
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Cassie Gregson

VP Head of AI Enterprise Process & Innovation Center, AstraZeneca, United States
avatar for Anton Mihic

Anton Mihic

Partner, McKinsey & Company, United States
Anton is a management consultant serving clients in McKinsey’s Life Science R&D practice across global PharmaCos, innovative Biotechs, CROs and Private Equity portfolio companies. Anton leads McKinsey’s global Regulatory Affairs, Safety and R&D Quality service line, and focuses... Read More →
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Ralf Raschke

Senior Expert, McKinsey & Company, United States
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Jennings Xu

Senior Director, Data Science & Digital Health, Johnson & Johnson Innovative Medicine, United States
Jennings Xu is Senior Director of Data Science at Johnson & Johnson, where he leads R&D Generative AI strategy, partners with Global Regulatory Affairs on end-to-end AI-enabled acceleration, and heads Asia-Pacific R&D Data Science. He oversees multidisciplinary teams across discovery... Read More →
Thursday June 18, 2026 8:00am - 9:00am EDT
109AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  03: Data-Tech-AI, Session |   04: MedAffairs-SciComm, Session |   08: RegPolicy-Strategy-GlobalCollaboration, Session
  • Audience Intermediate
  • Area Artificial Intelligence
  • Level Intermediate
  • format csv
  • Credit Type ACPE, CME, RN
  • Interest Area Health Technology & AI,Medical Affairs & Scientific Communication
  • Feature Topics Artificial Intelligence
  • Tags Session

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